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Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause
Phase 1, PHASE2 trial testing ACER-801 50 mg BID in Post-menopausal Vasomotor Symptoms in 49 participants. Completed in 4 March 2023.
| Lead sponsor | Acer Therapeutics Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 30 March 2022 |
| Primary completion | 4 March 2023 |
| Estimated completion | 4 March 2023 |
| Sites | 1 location across United States |
Acer Therapeutics Inc. — full company profile →
Adults 40 to 65, female only, with Post-menopausal Vasomotor Symptoms. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
maximum concentration of ACER-801 measured at Day 1 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
| Group | Value | 95% CI |
|---|---|---|
| ACER-801 50 mg BID | 10.78 | ± 8.97 |
| ACER-801 100 mg BID | 32.36 | ± 33.56 |
| ACER-801 200 mg BID | 41.75 | ± 30.69 |
maximum concentration of ACER-801 measured at Day 14 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
| Group | Value | 95% CI |
|---|---|---|
| ACER-801 50 mg BID | 27.47 | ± 22.09 |
| ACER-801 100 mg BID | 83.08 | ± 52.38 |
| ACER-801 200 mg BID | 168.28 | ± 89.68 |
peak concentration of ACER-801 metabolite measured at Day 1 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
| Group | Value | 95% CI |
|---|---|---|
| ACER-801 50 mg BID | 15.25 | ± 11.60 |
| ACER-801 100 mg BID | 43.77 | ± 44.58 |
| ACER-801 200 mg BID | 61.31 | ± 38.44 |
peak concentration of ACER-801 metabolite measured at Day 14 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
| Group | Value | 95% CI |
|---|---|---|
| ACER-801 50 mg BID | 38.79 | ± 27.56 |
| ACER-801 100 mg BID | 92.17 | ± 52.18 |
| ACER-801 200 mg BID | 196.80 | ± 92.74 |
time to reach maximum concentration of ACER-801 measured at Day 1 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
| Group | Value | 95% CI |
|---|---|---|
| ACER-801 50 mg BID | 1.29 | ± 0.66 |
| ACER-801 100 mg BID | 1.21 | ± 0.54 |
| ACER-801 200 mg BID | 1.33 | ± 0.58 |
time to reach maximum concentration of ACER-801 at Day 14 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
| Group | Value | 95% CI |
|---|---|---|
| ACER-801 50 mg BID | 0.96 | ± 0.33 |
| ACER-801 100 mg BID | 2.17 | ± 1.45 |
| ACER-801 200 mg BID | 1.79 | ± 0.75 |
time to reach maximum concentration of ACER-801 metabolite at Day 1 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
| Group | Value | 95% CI |
|---|---|---|
| ACER-801 50 mg BID | 1.38 | ± 0.53 |
| ACER-801 100 mg BID | 1.25 | ± 0.54 |
| ACER-801 200 mg BID | 1.33 | ± 0.54 |
Time to reach maximum concentration of ACER-801 metabolite at Day 14 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
| Group | Value | 95% CI |
|---|---|---|
| ACER-801 50 mg BID | 1.21 | ± 0.45 |
| ACER-801 100 mg BID | 2.21 | ± 0.92 |
| ACER-801 200 mg BID | 1.88 | ± 0.61 |
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method) Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
| Group | Value | 95% CI |
|---|---|---|
| ACER-801 50 mg BID | 42.32 | ± 37.02 |
| ACER-801 100 mg BID | 149.92 | ± 159.83 |
| ACER-801 200 mg BID | 205.94 | ± 156.95 |
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method) Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
| Group | Value | 95% CI |
|---|---|---|
| ACER-801 50 mg BID | 174.72 | ± 150.61 |
| ACER-801 100 mg BID | 517.91 | ± 346.91 |
| ACER-801 200 mg BID | 1252.54 | ± 769.07 |
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801 metabolite, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method) Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
| Group | Value | 95% CI |
|---|---|---|
| ACER-801 50 mg BID | 61.42 | ± 46.41 |
| ACER-801 100 mg BID | 172.18 | ± 165.54 |
| ACER-801 200 mg BID | 291.23 | ± 203.43 |
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801 metabolite, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method) Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
| Group | Value | 95% CI |
|---|---|---|
| ACER-801 50 mg BID | 257.56 | ± 200.63 |
| ACER-801 100 mg BID | 628.87 | ± 383.91 |
| ACER-801 200 mg BID | 1579.25 | ± 847.47 |
Time frame: 2 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | ACER-801 50 mg BID | ACER-801 100 mg BID | ACER-801 200 mg BID | Placebo |
|---|---|---|---|---|---|
| ventricular tachycardia | Cardiac disorders | — | — | — | — |
| Reaction | System | ACER-801 50 mg BID | ACER-801 100 mg BID | ACER-801 200 mg BID | Placebo |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | — | — | — | — |
| Vessel puncture site pain | General disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Vessel puncture site bruise | General disorders | — | — | — | — |
| Medical device site reaction | General disorders | — | — | — | — |
| nausea | Gastrointestinal disorders | — | — | — | — |
| flatulence | Gastrointestinal disorders | — | — | — | — |
| headache | Nervous system disorders | — | — | — | — |
| back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| pruritus | Skin and subcutaneous tissue disorders | — | — | — | — |
| xeroderma | Skin and subcutaneous tissue disorders | — | — | — | — |
| infusion site haemorrhage | General disorders | — | — | — | — |
| sensation of foreign body | General disorders | — | — | — | — |
| vessel puncture site erythema | General disorders | — | — | — | — |
| abdominal pain | Gastrointestinal disorders | — | — | — | — |
| diarrhoea | Gastrointestinal disorders | — | — | — | — |
| abdominal discomfort | Gastrointestinal disorders | — | — | — | — |
| breath odour | Gastrointestinal disorders | — | — | — | — |
| frequent bowl movements | Gastrointestinal disorders | — | — | — | — |
| gastritis | Gastrointestinal disorders | — | — | — | — |
| dizziness | Nervous system disorders | — | — | — | — |
| dysgeusia | Nervous system disorders | — | — | — | — |
| paraesthesia | Nervous system disorders | — | — | — | — |
| syncope | Nervous system disorders | — | — | — | — |
| muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — | — |
| neck pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| dry throat | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| nasal dryness | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| blister | Skin and subcutaneous tissue disorders | — | — | — | — |
| palpitations | Cardiac disorders | — | — | — | — |
| lymphadenitis | Blood and lymphatic system disorders | — | — | — | — |
| skin laceration | Injury, poisoning and procedural complications | — | — | — | — |
| decreased appetite | Metabolism and nutrition disorders | — | — | — | — |
| micturition urgency | Renal and urinary disorders | — | — | — | — |
| vessel puncture site swelling | General disorders | — | — | — | — |
Most-reported serious reactions: ventricular tachycardia.
Data from ClinicalTrials.gov NCT05325775 adverse events section.
In this clinical research study, subjects will be given the study drug, ACER-801 (osanetant) or placebo (looks like the study drug but contains no active ingredients). The study drug works on a receptor in the brain and the intended purpose is for the study treatment of moderate to severe Vasomotor Symptoms (VMS) also referred to as hot flashes or flushes associated with menopause. Hot flashes are a change in your temperature that occurs due to changes in your hormones.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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